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Under way, not recruiting

ROSA Knee System vs Conventional Total Knee Arthroplasty

NCT05685693 · Zuyderland Medisch Centrum · Updated 24 July 2024

What is being tested
Robotic-assisted total knee arthroplasty (raTKA); conventional total knee arthroplasty
For
Knee Osteoarthritis
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 40 years to 90 years. About 150 people. The full rules are on the registry page.
Where
Netherlands
When
Starts or started 16 Dec 2022, ends Dec 2035. Registered 17 Jan 2023.
Results
None posted yet.

In the researchers' words

This is a randomized clinical study, in which 150 patients with end-stage osteoarthritis will be enrolled to ROSA®-assisted knee arthroplasty or conventional knee arthroplasty. Patients are recruited at Zuyderland Medical Center, enrolled pre-operatively and followed up for 12 months post-surgery. In- and exclusion criteria are stated below. After recruitment, participants will be invited for a pre-operative visit. During this pre-operative visit Informed Consent is signed and completion of patient-reported outcome measures (PROMs) is checked. Additionally, measurements regarding body composition, strength and fitness and metabolic outcomes are performed. Participants will have a blood sample taken. Scans, adverse event and medication use will be confirmed. Participants will receive a ActiGraph for collecting data from physical activity. Of all patients, 72 will undergo additional measurements (gait, proprioception). During surgery ROSA- and surgery-data will be collected. Post-operative participants will have a 6-weeks, 3-month and 12-month visit. During these visits pre-operative measurements are repeated.
ClinicalTrials.gov, NCT05685693

Sites

  • Zuyderland Medical CenterSittard, Limburg, Netherlands